drugset / Trial / NCT07610733

Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients.

NCT07610733

Phase 2 Not yet recruiting 100 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, prospective, randomized controlled, phase II study. The primary objective is to evaluate the effect of endocrine therapy modification (switching from a 3-month to a 1-month GnRHa) versus continuation of the 3-month GnRHa on E2 control at 3 months in young patients with hormone receptor-positive breast cancer and iOFS.

Timeline

Start
2026-06-01
Primary completion
2027-09-01
Completion
2030-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Goserelin Other / unclassified 3.6 mg
Subject Goserelin Other / unclassified 10.8 mg
Subject Leuprolide Other / unclassified 3.75 mg
Subject Leuprolide Other / unclassified 11.25 mg
Background Tamoxifen Small molecule

Indications